Vivus Inc announced that data from a recently completed phase 2 clinical trial demonstrated that Alista significantly increased the percentage of satisfying sexual events in premenopausal women with female sexual arousal disorder (FSAD) when compared with placebo. Sixty-four per cent of Alista doses resulted in satisfying sexual events (p<0.05).

The study also showed patients experienced an increase in the total number of satisfying sexual encounters when compared to placebo (p=0.05). This double-blind, randomized, placebo-controlled, crossover study evaluated the efficacy and safety of Alista for premenopausal women in the home setting. In this study, involving six different sites, 36 women received at least one dose each of the placebo and active drug.

Women rated Alista as providing an increase in their level of sexual arousal (p<0.01) and a decrease in level of distress (p<0.05) when compared to placebo. Sexual arousal was evaluated through the use of a daily diary and level of distress was evaluated through the use of an industry standard questionnaire.

"This is the third phase 2 study of Alista showing clinically significant improvements in sexual satisfaction among participants," said Leland Wilson, Vivus' president and chief executive officer. "These results in premenopausal women are consistent with previous results from studies in postmenopausal women. Success in this study has greatly increased the potential market for Alista. Vivus plans to include clinical trials in premenopausal women in the Alista phase 3 development programme," he added.

Vivus is entering phase 3 clinical development with Alista, a topical formulation of alprostadil, for the treatment of female sexual arousal disorder (FSAD). Alprostadil is thought to increase blood flow to the genital tissues in females, which could improve sexual function. Alista phase 2 clinical data in postmenopausal women using the product at home demonstrated improved arousal.

The full results from this Phase 2 study will be presented at a scientific forum later this year.